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update:change in tx time: 24 wk instead of 48 wks !
I consulted with my doctor’s colleage.
My original doctor suggested that I treat for 48 wks.  But, this new doctor said I can treat for 24 wks.
I am TT, biopsy 2/2,  and my first tx was soc and I reached und at wk 16, but decided to stop tx and wait for new PI.
On 9/28/11, I started triple tx with incevik and was und at week 2.  I have been on a riba reduction because of low HGB (started riba at 1000 mg, and about week 10 reduced to 800 mg,  and around week 11 reduced to 600 mg and am currentlystill on 600 mg) and I hope this doesn't affect the outcome.  With this 24 wk course, it turns out I am now more than half way done !

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That is fantastic news!  Best to you

Jules
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Hi Ginger.
I guess this was breaking new ground in a way. being that you were UND on SOC at week 16 .then you could be considered a "relapser" ,however possibly  when you started triple the doctor thought .you could be classified as a prev. "partial ",given the slow response..
Being that you were UND. at week 4 this time and for 'relapsers" 24" is the recommended time and with great success...they have changed course.

Great news and glad you are on the home stretch!.
Will
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Smart move i do believe...............Best to you.

That was my thoughts all along.
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408795 tn?1324939275
Great news!!  Time off for good liver!! lol  Good for you!!  Good luck with the rest of your journey!
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I know you are happy!
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1800762 tn?1326409764
My doctor also was thinking about 48 weeks for me. Last visit she told me I can go off at 24 weeks. I just finished my meds last week so now I am hoping to stay und. I was also und at week 2. I am a relapser I did tx twice before and was und until i went off meds. My dr. said now i have 87% chance of staying und.
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1654058 tn?1407162666
Congrats to you! I know you feel so good that the end is closer. I had several weeks reduced RIBA too n remained UND. I'm trying to stay full dose for the remainder, but I started ESLD diagnosis. I'm crossing my fingers for us both!
Karen :)
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190885 tn?1333029491
sounds great ginger...good luck and keep us posted....billy
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Really good news! I don't have to do 48 anymore either, so happy for you.
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Great news!  Congratulations.  Seems like a good decision.
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419309 tn?1326506891
Getting even closer to the end now! With the 2 week undetected, the odds are definitely in your favor for SVR.  Nothing like a shorter course to make for a brighter day... congratulations on getting the good news!  Best wishes for undetecteds forever! ~eureka
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thanks all.   your feedback has always helped me along.  i wish you all the same.   ginger
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446474 tn?1446351282
I hate to put a damper on the though of only treating for 24 weeks but the
"new doctor" is misinformed. I wish it wasn't the case but the duration for treatment is unambiguous.

Will, Bill and Eureka please check my facts in hopes that I am misunderstanding something. I was up at the hospital for many hours today am I am pretty brunt out so maybe I am missing something obvious.

According to the "HIGHLIGHTS OF PRESCRIBING INFORMATION" for Incivek I believe your first doctor was correct. Inorder to have the highest chance of SVR (59%) you must treat for 48 weeks as all "Prior non-responders" should.

You can also go to the Invivek Dosing and Administration page.
http://www.incivek.com/hcp/treatment-duration-treatment-history
"In prior partial and null responders, total treatment duration of 48 weeks is required."

ONLY in "treatment-naïve" and "prior relapser" patients, response-guided therapy (RGT) is used to determine total treatment duration. You are definitely are not part of this group. You are not treating for the first time, and you never completed treatment and only after stopping treatment did the virus come back.

Here is a link to the PDF file.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

14.3 Previously Treated Adults
Study C216 (REALIZE)
"Prior non-responders" (subjects who did not have undetectable HCV-RNA levels during or at the end of a prior course of at least 12 weeks of treatment).
Table 11: Response Rates: T12/PR48 SVR rate = 59% (57/97)

Duration of Treatment
The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV-RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).

Table 1:
Prior Partial and Null Responder Patients
Total Treatment Duration - 48 weeks

You can always call Vertex free 24/7 nurse support 24/7 to get the answer.
Vertex GPS:
Guidance & Patient Support
1-855-VERTEX-GPS (1-855-837-8394)

Good luck Ginger!
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419309 tn?1326506891
I'm not sure if not reaching undetected until week 16 necessarily makes her a partial- or non-responder... technically she was undetected "at the end of a prior course of at least 12 weeks of treatment"(14.3), so in my mind she could qualify for being a possible relapser, having indeed reached undetected during prior treatment.  In my mind, being a partial-responder would be 2 log drop but no undetected.
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Don't see your logic Hector, she had a 2 log drop by week 12 and was und by week 24........ Her prior doctor could have been foolish and kept her on tx for 48 weeks so she was an "offical relapser" but why???

I remember there were alot of doctors during this time saying to stop tx like was in her case because of these new meds "coming soon". I believe they made the right call then and are doing so now........ But i'm not the expert.
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14.3 Previously Treated Adults
Study C216 (REALIZE)
Study C216 was a randomized, double-blind, placebo-controlled, trial conducted in subjects who did not achieve SVR with prior treatment with Peg-IFNalfa-2a/RBV or Peg-IFN-alfa-2b/RBV. The study enrolled prior relapsers (subjects with HCV-RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow-up) and prior non-responders (subjects who did not have undetectable HCV-RNA levels during or at the end of a prior course of at least 12 weeks of treatment). The nonresponder population included 2 subgroups: prior partial responders (greater than or equal to 2-log10 reduction in HCV-RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with peginterferon alfa and ribavirin) and prior null responders (less than 2-log10 reduction in HCV-RNA at week 12 of prior treatment with peginterferon alfa and ribavirin).

It seems she was und at the end of tx and she did complete at least 12 weeks, since she was und that would rule her out of the 2 subgrougs of prior partial responders and prior null responders
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As I mentioned to GIINGER in my post above..her case could be some new ground.
Being that she did achieve UND. during her therapy(albeit total therapy was only 16 wks) what would she be classified as doing the triple.
As Eureka and cando state  technically this would mean a "relapser",however to me that may be a bit of a grey area in the classification.
If I was the patient in this circumstance ,because I was a prev. "slow" responder and given the fact I am a TT allele ,I would personally give thought to extending ,especially if I was tolerating treatment well.
However there is always the  balance of Risk vs. benefit  that must be weighed of over exposure to therapy.

Her doctor seems confident in the 24 weeks and As cando states..they are the experts..

JMO..

Will

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"and given the fact I am a TT allele" ,  meant Ginger is a TT.

..I don"t know what alelle I am...

Will
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179856 tn?1333550962
I guess this is a case of we shall see if she SVRs or not and then we'll have some more information. She's kind of like a trial it can go one way or the other.

I always look at it with the same eyes as before with a 75% success rate and a history that is less than stellar I would have listened to the first doctor just hoping against hope it would make 'the' difference, but with these new meds who knows.

It's still a lot of up in the air and I guess it depends on how much risk / discomfort you are willing to take to get that SVR in these situations when things are grey.
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Good morning all, maybe someone can help me out here as i keep drawing a blank on this, its clear that she qualified during SOC to treat the 48 weeks. If she had and then relapsed there would not be a question on her tx now sense she was better then a eRVR (und at week 2) right???

So the only thing i can think that would have changed that would have been a viral breakthrough during SOC. But viral breakthroughs are very rare, as a matter of fact in one trial with telaprevir people on SOC (p/r48) breakthroughs were only 3%, way to low of a risk to justify 24 more weeks of tx. Alot of doctors don't even do a EOT PCR because its so low. As for being a slow responder i find nothing saying they should do 48 weeks, and if I'm correct an und at only 2 weeks trumps being a tt......... As most know here i am all for going the extra mile and feel rescue drugs should be used before dose reducing....... Someone help me here.
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I agree that if she had of done the full course on her SOC then as you say there would have been no question of her doing only 24 this therapy because of the current eRVR,however The grey area I mentioned is the length in total she did.
There is no data ,as you mention "slow responders " fare better with 48,however given that she was a pEVR and not a cEVR on her last tx.  and the fact the definition of a "true relapser "( below.).I thought at least some consideration to 48 was warrented.
As I mentioned cando,it was just my opinion and if it was myself I may consider extending,,even if not for another 48 then possibly some weeks longer,however her doctor is the expert as you say..however I wonder if the first doctor was an expert also?
Hope it all works out in the end....
Will

http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0401_2010_b.html

Prior Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.

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Thanks will, it looks like she doesn't fit in anywhere by that, it will be interesting to see how others are treated, at the time it seemed like a wise move in doctors by stopping tx early....... But now just more confusing. I guess thats why they get paid the big bucks...

Prior Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.

Prior Partial Responder: Defined as a person who achieved at least a 2 log10 reduction in HCV RNA at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy.

Prior Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy.
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